Prescribe Right
Prescribe Right
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
Pipeline News and Updates
Picture

Weekly Update for the Week Ending December 21, 2019

12/30/2019

 
Regulatory Update

The FDA approved for lemborexant (Dayvigo, Eisai) on 12/23/19 for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

The FDA approved for lumateperone (Caplyta, Intra-Cellular Therapies) on 12/23/19 for the treatment of schizophrenia in adults. Lumateperone has a boxed warning due to an increased risk of death for elderly patients with dementia-related psychosis. The label also contains a warning for increased risk for cerebrovascular events in this population.

The FDA approved ubrogepant (Ubrelvy, Allergan) on 12/23/19 for the acute treatment of migraine with or without aura in adults.

Announced Research Updates

Shanghai Green Valley Pharmaceutical plans to initiate an 18-month, 2,046 patient, Phase III trial in the U.S. and Europe in 2020 that will evaluate oligomannate in the treatment of mild-to-moderate Alzheimer's disease. Results were announced in the fall of 2019 from a 9-month trial, which found oligomannate slowed the decrease in the ADAS-Cog12 Score compared to placebo. While researchers were skeptical due to the short duration of the trial and lack of details, the results led to conditional approval in China. The new trial is being undertaken to answer questions about the drug from the FDA and EMA.

Published Research Updates

In a 312 patient, Phase III trial,  pixantrone/rituximab did not improve progression free survival compared to gemcitabine/rituximab in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after ≥1 rituximab-containing regimen and were not eligible for a stem cell transplant.

The World Health Organization recommended fexinidazole as a first-line treatment option for human African trypanosomiasis. The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) recommended approval of fexinidazole for the treatment of human African trypanosomiasis (HAT), more commonly known as sleeping sickness. CHMP gave the opinion under Article 58, which is designed to provide guidance for drugs that are intended for use in countries outside the European Union. Fexinidazole was approved for use in the Democratic Republic of the Congo.

Comments are closed.
    Stay informed, subscribe to the 
    ​
    Prescribe Right Pharmaceutical Pipeline Tracker
    Latest Tweets from Prescribe Right

    Archives

    January 2023
    December 2022
    October 2022
    September 2022
    August 2022
    July 2022
    June 2022
    May 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    August 2015

    RSS Feed

Services

Pharmaceutical Pipeline Tracker​
Consulting

Company

About
Blog
Tweets

Support

Contact
© COPYRIGHT 2015. ALL RIGHTS RESERVED.